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Medical devices functional safety services from SGS – testing, certification and testing for compliance with Medical Devices Directive 93/42/EEC.

CT scanner

Medical device manufacturers must obtain certification against the CE marking directive from a Notified Body before using the CE mark and placing products on the market. Our functional safety team delivers these services for active/electrical medical devices and testing in accordance with:

  • IEC 60601-1 3rd Edition
  • Programmable electrical medical systems IEC 60601-1-4
  • Software-Life Cycle according to IEC 62304
  • IEC 61508

In addition, we provide help to manufacturers of medical software applications (APPs) with their CE conformity declaration:

  • Training on the procedures and requirements of the CE manufacturer declaration of Medical Device Directive 93/42/EEC (MDD), Annex VII
  • Clarification of the applicable medical device standards
  • Examination of documents to be submitted

CE mark and sell medical devices in Europe with medical device directive, 93/42/EEC, certification from SGS. Contact your local office today to find out more.